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RecruitingNCT07781644TARBELA-PDUpdated Nov 9, 2026

Study to Test Effects and Safety of RO7568282 in Early Parkinson's Disease

A Phase 2 interventional study of RO7568282 and Placebo in Parkinson's Disease, sponsored by Hoffmann-La Roche. Recruiting at 4 sites in 3 countries. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment

Updated Nov 9, 2026Now RecruitingFirst sites in United Kingdom, China and United States+4 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
474
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of RO7568282 compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.

02

Conditions studied

  • Parkinson's Disease

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03

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's planned enrollment of 474 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.

Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.

Browse Hoffmann-La Roche studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Must be aged 40 to 85 years inclusive
  • Diagnosis of idiopathic PD
  • Has received stable doses of monotherapy treatment with levodopa for at least 2 months prior to baseline
  • Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV score of 0 at screening and prior to randomization at baseline
  • Hoehn and Yahr (H\&Y) Stage ≤ 3 (assessed in off medication state) at screening and prior to randomization at baseline
  • Able to swallow whole capsules

Exclusion criteria

Exclusion Criteria:

  • Medical history indicating a parkinsonian syndrome other than idiopathic PD
  • Diagnosis of PD dementia
  • Diagnosis of a significant neurologic disease other than PD
  • Within the last year, unstable or cardiovascular disease
  • Chronic uncontrolled hypertension
  • History or presence of brain magnetic resonance imaging (MRI) scan showing evidence of structural abnormalities, other than related to PD

Note: Other protocol-defined inclusion/exclusion criteria also apply

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
474 participants (estimated)

Study arms

  • Experimental
    RO7568282 High Dose

    RO7568282 will be administered as per the schedule specified in the protocol.

    Drug: RO7568282

  • Experimental
    RO7568282 Low Dose

    RO7568282 will be administered as per the schedule specified in the protocol.

    Drug: RO7568282

  • Placebo comparator
    Placebo

    Placebo will be administered as per the schedule specified in the protocol.

    Drug: Placebo

Interventions

  • DrugRO7568282

    RO7568282 will be administered as per the schedule specified in the protocol.

  • DrugPlacebo

    Placebo will be administered as per the schedule specified in the protocol.

06

What researchers measure

Primary outcomes

  1. Time to a Confirmed Motor Progression Event From the Randomization Date, as Measured by the MDS-UPDRS Part III Score

    Time frame: Up to at least Week 104

Secondary outcomes

  1. Change in Motor Signs From Baseline at Week 104, as Measured by the MDS-UPDRS Part III Score

    Time frame: Baseline and Week 104

  2. Time to Worsening of Participants' Motor Function, as Reported by the Participant in the Presence of a Confirmed Motor Progression Event

    Time frame: Up to at least Week 104

  3. Incidence of Adverse Events (AEs)

    Time frame: Up to at least Week 104

  4. Change From Baseline in Columbia-suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to at least Week 104

  5. Plasma Concentrations of RO7568282

    Time frame: Up to at least Week 104

07

Study locations

4 of 4 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

09

Updates

2 registry updates since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Nov 9, 2026
Sites
4 sites added — first sites in United Kingdom, China and United States. 2 sites changed recruiting status (2 now recruiting)
Show 2 sites
  • Ninewells Hospital, Dundee- Scotland · Dundee, United Kingdomno status→Recruiting
  • Royal London Hospital · London, United Kingdomno status→Recruiting
Show 4 added (2 United Kingdom, 1 United States, 1 China)
  • Ninewells Hospital, Dundee- Scotland · Dundee, United Kingdom
  • Royal London Hospital · London, United Kingdom
  • Parkinson's Disease and Movement Disorders Center of Boca Raton · Boca Raton, United States
  • Huashan Hospital, Fudan University · Shanghai, China
across 2 updates, Oct 20, 2026 – Nov 9, 2026
Start date
Sep 30, 2026→Nov 10, 2026
Nov 9, 2026
Design
Removed Phase 1
Nov 9, 2026
Show all 2 updates
  1. Nov 9, 2026
    Not yet recruiting→Recruiting
    2 sites added — first sites in China and United States. 2 sites changed recruiting status (2 now recruiting)
    Show 2 sites
    • Ninewells Hospital, Dundee- Scotland · Dundee, United Kingdomno status→Recruiting
    • Royal London Hospital · London, United Kingdomno status→Recruiting
    Show 2 added (1 United States, 1 China)
    • Parkinson's Disease and Movement Disorders Center of Boca Raton · Boca Raton, United States
    • Huashan Hospital, Fudan University · Shanghai, China
    Start date Sep 30, 2026→Nov 10, 2026
    Design Removed Phase 1
    + 1 other change: verification date
  2. Oct 20, 2026
    2 sites added — first site in United Kingdom
    Show 2 added (2 United Kingdom)
    • Ninewells Hospital, Dundee- Scotland · Dundee, United Kingdom
    • Royal London Hospital · London, United Kingdom
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07781644
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Aug 24, 2026
Start date
Nov 10, 2026 (estimated)
Primary completion
Dec 15, 2028 (estimated)
Completion
Apr 15, 2032 (estimated)
Last update
Nov 9, 2026

Study contacts

Reference Study ID Number: BP46441 https://forpatients.roche.com/ No email attachments.
Contact
global-roche-genentech-trials@gene.com
888-662-6728
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Contact
Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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